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Molecular Breast Imaging Guidance for Breast Biopsy for Patients With Breast Abnormalities

ConditionBreast Neoplasm
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMayo Clinic

About this trial

This clinical trial tests how well molecular breast imaging (MBI) works to guide the collection of a breast biopsy in patients with a breast abnormality. Currently, a biopsy is often guided by either ultrasound or mammography in order to ensure that a sample of the correct part of the breast is taken. Sometimes a lesion or part of the lesion cannot be seen on ultrasound or mammography, and, therefore, a biopsy guided with ultrasound or mammography may not be always be accurate. Studies have shown that high resolution MBI may have potential to improve the detection of some breast tumors. This trial uses a new high-resolution MBI system that may help perform a biopsy using MBI.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

PART I: Women aged 18 years or older

PART I: If able to become pregnant, negative pregnancy test within 48 hours prior to MBI biopsy procedure

PART I: Individuals who have previously (within the last 3 years) undergo an MBI study and were found to have at least one breast imaging finding on MBI that was subsequently shown (through additional imaging, biopsy or follow-up) to be benign in nature

PART I: Individuals who have agreed to participate in the study and who have signed the study-specific informed consent

Disqualifiers

PART I: Women who are pregnant

PART I: Women who are currently lactating or discontinued breastfeeding < 2 months prior to the study

PART I: Age less than 18 years

PART I: Women with breast implant(s) in the breast containing the lesion of interest

Trial design

Design model

Sequential

Treatments tested in this trial

  • Biopsy of Breast

    Procedure/Surgery

    Undergo biopsy of breast

  • Medical Device Usage and Evaluation

    Other intervention

    Utilization of the Stereo Navigator accessory

  • Scintimammography

    Radiation

    Undergo MBI

  • Technetium Tc-99m Sestamibi

    Other intervention

    Given IV

Treatment groups

70 Participants
are divided into 2 treatment groups
Group A: Part I (technetium Tc-99m sestamibi, MBI)Experimental treatment 2 interventions
Group B: Part II (technetium Tc-99m sestamibi, MBI, biopsy)Experimental treatment 4 interventions

Trial outcomes

Primary outcomes

1

Validation of timeframe

Time from injection of the technetium Tc-99m sestamibi to identification of the appropriate needle guide hole will be reviewed to determine if and where any improvements in workflow can be made to reduce the overall procedure time for patients.

Time frame
Baseline
2

Change in image of lesion

The coordinates of the lesion of interest on the high resolution MBI image will be recorded. The guidance procedure will be considered successful if 1) the pre and post images of the lesion demonstrated one of the following: decreased in size, central or eccentric defect where sampled, or decrease in intensity, or 2) pathology results demonstrate malignancy or a specific benign concordant result.

Time frame
Baseline; Up to 6 months
3

Accuracy of depth estimation by difference in attenuation from opposing views

For each patient in whom pathology confirms successful sampling of the lesion seen on high-resolution molecular breast imaging (MBI), the error in depth estimation will be calculated as the average error for each depth estimation method from all core biopsy samples. This will allow comparison of the accuracy of the 3 different depth estimation methods and potentially provide further information on the strengths and weakness of each of the three methods for depth estimation. Uniformity activity along the entire 20 mm core would indicate failure to biopsy the lesion. Any portion of increased uptake will be noted and the center of activity will be determined relative to the mid-point of the core sample. This distance will be recorded as the difference between estimated depth and true depth.

Time frame
Baseline; Up to 6 months
4

Accuracy of depth estimation by difference in apparent lesion size

For each patient in whom pathology confirms successful sampling of the lesion seen on MBI, the error in depth estimation will be calculated as the average error for each depth estimation method from all core biopsy samples. This will allow comparison of the accuracy of the 3 different depth estimation methods and potentially provide further information on the strengths and weakness of each of the three methods for depth estimation. Uniformity activity along the entire 20 mm core would indicate failure to biopsy the lesion. Any portion of increased uptake will be noted and the center of activity will be determined relative to the mid-point of the core sample. This distance will be recorded as the difference between estimated depth and true depth.

Time frame
Baseline; Up to 6 months

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Source ClinicalTrials.gov
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